Breaking News…The Pink Vaccine is Coming! Clinical Trials to begin in 2015

In In The News by Barbara Jacoby

Thumbnail for 8911For the past eleven years there has been a dream in the making; a world without breast cancer. This dream was based on a vision to eradicate the disease using a revolutionary approach; that of immune prevention.  Breast cancer immunoprevention was and continues to be the mission of Dr. Vincent K. Tuohy and his team at the Learner Research Institute at the Cleveland Clinic in Cleveland, Ohio.  While others searched for new treatments, Dr. Tuohy and his team focused all efforts on preventing the disease before it had a chance to get started.

The road to proving his theory has been a long and arduous one.  His premise seemed simple but was so unique that it seemed impossible.  Dr. Tuohy noted that we have an extensive childhood vaccination program to protect us as children from dangerous infectious diseases, but we have no primary vaccination program to protect us as adults against diseases we confront with age like breast cancer.  As Dr. Tuohy says, “We are advocating that control of breast cancer must involve a strong defense that could be provided by a vaccine that induces safe and effective preemptive immunity against emerging tumors.” Dr. Tuohy designed the vaccine by targeting ‘retired’ self-proteins that are no longer expressed with age at immunogenic levels in normal tissues but are expressed in newly invigorated emerging breast tumors.  Quite simply, he proposes to aim the immune system at target proteins that are no longer present in aging tissues since they are no longer needed, but are found to be present in many breast cancers.

One such protein is alpha-lactalbumin. Dr. Tuohy studied the breast tumor cells of mice specifically bred to develop breast cancer.  These same mice are used to test new treatments and their tumors are remarkably similar to human breast cancers.  He discovered that these mouse tumors overexpressed the alpha-lactalbumin protein.  This gave birth to the ‘retired’ protein hypothesis whereby such retired proteins could be used as targets for developing preventive vaccines against adult onset cancers.  Dr. Tuohy tested his hypothesis in numerous mouse models with substantial success.  So what challenge remained?  Quite simply…the lack of funding for clinical trials.

The tide turned on September 17, 2013 with the long awaited announcement that anonymous private investors had stepped forward to fund the clinical development of the vaccine.  The newly formed company called Shield Biotech, has provided the resources to fund human clinical trials and facilitate Dr. Tuohy’s dream to make this vaccine a reality.  The vaccine is now moving forward from bench-to-bedside, but the excitement doesn’t end here.  Dr. Tuohy’s vaccine is likely to be most effective in preventing the most aggressive and lethal form of this disease known as triple negative breast cancer (TNBC).

Recently the details of the design of the clinical trials were announced and published.  The complete publication is available on  The direct link to the article is:

So what’s next? The first phase of human trials is planned for beginning sometime during 2015.  The first step is to determine dosage and safety of the vaccine.  The initial phase Ia clinical trial for dosage and safety will involve women who already have TNBC and will be offered the vaccine to prevent recurrence of the disease whereas.  A second phase Ib trial will then incorporate women at high genetic or familial risk for breast cancer who opt for prophylactic mastectomy to reduce their risk.  Consenting women will be vaccinated prior to mastectomy and their breast tissues will be assessed thoroughly for inflammation and tissue damage to assess the safety of the vaccine.  These phase I trials for dosage and safety are expected to take several years to complete.

How can you help?  Dr. Tuohy’s team still needs financial support to continue their basic research to identify other targets for preventing other forms of breast cancer.  You may donate on  Please note that 100% of all donations go directly to Dr. Tuohy’v breast cancer vaccine research program with none of the donations going to any administrative or other extraneous costs.

Know someone who owns an auto repair shop?  An incredible campaign which began in Cleveland known as “Brakes for Breasts” is sweeping the nation during October and Breast Cancer Month.  Last year over $64,000 was raised for the vaccine fund, and this year’s goal is $100,000.  For more information or to register, visit:

To quote the “Brakes for Breasts” website: “This fundraiser is a win-win for everybody. Your clients receive FREE Brake Pads or Shoes and they pay for labor and any other ancillary parts needed. Your Vendor supplies you with the FREE Brake Pads or Shoes and in return you purchase all other parts for that job from that Vendor. At the end of the fundraiser your shop donates 10% of the proceeds from the brake jobs to the Cleveland Clinic Breast Cancer Vaccine Fund.”

Help put the “Brakes on Breast Cancer.” Be part of the revolution to wipe out this horrible disease that is taking our mothers, sisters, daughters and friends.  Help us build a future where we can tell our children that we were not only there when the first breast cancer vaccine was discovered; we were part of the movement that helped make it a reality.

In Dr. Tuohy’s words, “Prevention is the Cure.” I say,“The Pink Vaccine is the answer.”

Article author Judy Medeiros Fitzgerald is the  founder of Sisters4Prevention She is a Champion for the Pink Vaccine and a tireless advocate for the First Preventive Breast Cancer Vaccine developed by Dr. Vincent Tuohy at the Learner Institute of the Cleveland Clinic.